Identity
- Trade Name
- BLACK NITRILE GLOVES EUDAMED
- Device Name
- Disposable Nitrile Examination Gloves, Powder Free EUDAMED
- Model / Reference
- PNBB 10015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978719511725 EUDAMED
- Basic UDI-DI
- 697024575Nitrile7G EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Black Nitrile Gloves by Shandong Intco Medical Products Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697024575Nitrile7G | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Intco Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000002100
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED ca010d21-7ac2-4c08-bd82-24d1101ce5e7 61 fields · synced Jun 19, 2026